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510(k) K252174

AquaCast Mask by Blessing Cathay Corporation — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2025
Date Received
July 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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